Michael Hilgers Email & Phone Number

Scientist and project leader with broad experience in medical device R&D and in vitro diagnostics manufacturing. Experience includes:• Collaboration with scientists, engineers, manufacturing, purchasing, quality and clinical affairs • Medical device research and development • In vitro diagnostics manufacturing• Medical device prototype development, feasibility and validation.• Glucose monitoring and body fluid extraction• Experimental design, data collection and analysis (JMP and Minitab). • Six Sigma and LEAN trained• cGMP in FDA compliant environment• ISO 13485:2003 Internal Auditor for Medical Device Management Systems•Supplier relationshipsTechnical skills include:• Infrared, UV-Visible spectroscopy, protein gel analysis, chemiluminescent immunology• Needle/microneedle design and test method development and • Anti-thrombogenic coatings

Listed skills include R&D, Medical Devices, Cross Functional Team Leadership, Fda, and 33 others.